STA5063Z - Design Of Clinical Trials

15 credits at NQF level 9

Entry Requirements:

Acceptance into Master’s program in Biostatistics, or statistical background deemed sufficient by the Head of Department.

Course Outline:

This module will look at the Design of Clinical Trials. Concepts of randomisation, replication and blocking will be discussed. Students will be introduced to the different phases, that is Phases I, II, III, and IV, of trial designs. Specific designs which will also be covered include, inter alia, randomised trials, dose-escalation studies, cross-over trials, PK/PD studies, designs for survival studies and multi-centre trials. The implications of the specific design for the analysis of the data will be discussed. the course may not be offered every year.